BR112015033068B1 - SAFETY SYRINGE - Google Patents

Abstract

safety syringe. one embodiment is directed to a safety syringe system comprising a syringe body; a plunger tip positioned within the syringe body; a needle assembly detachably attachable to the distal end of the syringe body, so that a medical fluid can be transferred through a retractable needle attached to a needle housing comprising the needle assembly upon insertion of the plunger tip into relation to the syringe body; and a plunger control assembly coupled to the plunger tip and configured to facilitate manual insertion of the plunger tip relative to the syringe body; wherein, upon insertion and release of the plunger tip, a retraction load coupled between the syringe body and the plunger tip causes the plunger tip to be withdrawn proximally, pulling the retractable needle proximally to the needle housing to a safely locked and retracted state.

Description

Related Order Data

[0001] The present application claims benefit under 35 U.S.C. §119 to United States Interim Patent Application Serial Number 61/841,702, filed July 1, 2013. The preceding Application is incorporated herein by reference to the present Application in its entirety.

Field of Invention

[0002] The present invention relates generally to injection systems, devices and processes to facilitate various levels of control over fluid infusion, and more particularly to systems and methods related to safety syringes in care settings. with health.

Background of the Invention

[0003] Millions of syringes, such as the one depicted in Figure 1A(2), are consumed in healthcare settings every day. A typical syringe (2) comprises a tubular body (4), a plunger (6) and an injection needle (8). As shown in Figure 1B, such a syringe (2) can be used not only to inject fluid into a patient, but also to extract or expel fluid into or out of a container, such as a medicine bottle, vial, pouch or another medication containment system (10). In fact, because of regulatory restrictions in some countries, such as the United States, as well as sterility maintenance concerns, when using a drug bottle (10) with a syringe (2) as shown in a patient's environment in particular, such a drug bottle can only be used with a single patient and must therefore be disposed of – leaving significant medical waste when disposing of the remaining drug and bottle, and even contributing to periodic shortages of certain critical drugs. Referring to Figure 2A, three Luer-type syringes (12) are shown, each having a distally located Luer connection geometry (14) so that they can be coupled to other devices that have a similar coupling geometry, such as as the Luer collector assembly (16) shown in figure 2B. The Luer connectors (14) of the syringes in Figure 2A may be called "male" Luer connectors, while those in Figure 2B (18) may be called "female" Luer connectors; one of the Luer interfaces can be threaded (in which case the configuration can be said to be a "Luer lock" configuration), so that the two parts can be coupled by relative rotation, which can be combined with compressive loading. In other words, in a Luer lock embodiment, rotation, possibly together with compression, may be used to engage threads within the male connector which are configured to engage a flange over the female connector and hold the devices together to form a watertight coupling. fluids. In another embodiment, tapered interface geometries can be used to provide a Luer coupling using non-threaded compression or rotation (such a configuration may be referred to as a tapered or "slip-on" Luer configuration). While such Luer couplings are recognized to be relatively safe for operators, there is a risk of drug leakage/spill and breakage of parts during loading to provide a Luer coupling. The use of needle injection configurations, on the other hand, carries with it the risk of a thin needle contacting or impaling an unwanted person or structure. For this reason, so-called "safety syringes" were developed.

[0004] An embodiment of a safety syringe (20) is shown in figure 3, in which a tubular protection element (22) is tensioned by a spring to cover the needle (8) when released from a locked position with respect to to the syringe body (4). Another embodiment of a safety syringe (24) is shown in Figures 4A-4B. With such a configuration, upon complete insertion of the plunger (6) with respect to the syringe body (4), the retractable needle (26) is configured to retract (28) back into a secure position within the tubular body (4), as shown in figure 4B. Such a configuration, which is configured to collapse in on itself, can be associated with bloodstain/aerosolization problems, safe storage of pre-charged energy, which can cause possible malfunction and activation earlier than desired, loss of accuracy in the administration of full-dose injections due to residual dead space within the spring compression volume and/or loss of control of the retraction rate which may be associated with pain and anxiety for the patient.

[0005] To further complicate the syringe market, there is a growing demand for pre-filled syringe sets, such as the one shown in Figure 5A, which generally comprise a syringe barrel, or "dispensing system". closed drug containment" (34), a plunger tip, plug or stop (36), and a seal or distal cap (35) that can be connected over a Luer-type interface. The liquid medication may reside in the volume, or medication reservoir (40), between the distal seal and the distal end (37) of the plunger tip (36). Such kits are desirable because they can be standardized and accurately produced in volume by the few manufacturers in the world who can afford to meet all of the world's ever-changing regulatory requirements for filling, packaging, and material selection for drug/drug interface and use. of components. Such simple configurations, however, often do not meet new worldwide standards for single-use, safety, self-disabling, and needle prick prevention. Thus, certain providers have switched to more "vertical" solutions, such as the one (41) characterized in Figure 5B, which tries to meet all standards, or at least a part of them, with a single solution; as a result of trying to meet these standards for many different scenarios, such products may have significant limitations (including some of those described above with reference to Figure 34B) and relatively high inventory and usage expenses.

[0006] There is a need for improved injection systems which address the shortcomings of currently available configurations. In particular, there is a need for safety injection solutions that can utilize the existing and relatively well-controlled supply chain of conventionally distributed pre-filled syringe sets, as described with reference to Figure 5A.

Summary of the Invention

[0007] One embodiment is directed to a safety syringe system comprising: a syringe body that forms a fluid reservoir and that has proximal and distal ends; a plunger tip positioned within the fluid reservoir in a configuration such that medical fluid can be contained within the fluid reservoir; a needle assembly detachably attachable to the distal end of the syringe body, so that medical fluid can be transferred through a retractable needle attached to a needle housing comprising the needle assembly upon insertion of the plunger tip into relation to the syringe body; and a plunger control assembly coupled to the plunger tip and configured to facilitate manual insertion of the plunger tip relative to the syringe body; wherein, upon insertion of the plunger tip into a final insertion state and release of an associated manual insertion load, a retraction load coupled between the syringe body and the plunger tip causes the plunger tip to be proximally withdrawn by pulling the retractable needle proximally with respect to the needle housing into a retracted state where a distal tip of the needle becomes mechanically locked into an encapsulated configuration where it is no longer exposed for injection. The fluid reservoir may comprise a substantially cylindrical volume. The syringe body may comprise a glass material. The syringe body may comprise a polymeric material. The plunger tip may comprise an elastomeric material. The elastomeric material may comprise a butyl based rubber. The needle may comprise a hypodermic needle. The hypodermic needle may comprise a standard size between about one gauge 20 and about one gauge 34. The needle assembly may comprise a movable needle insertion prevention member configured to prevent reinsertion of the needle with respect to the syringe barrel after the needle has been placed in the retracted state. The insertion prevention member may be configured to travel along an axis that is substantially perpendicular to a longitudinal axis of the needle. The system may further comprise a release member operatively coupled to the insertion-prevention member and configured to remove an insertion-prevention member's attachment restriction when the plunger tip reaches the final insertion state. The release member may comprise a pressure member configured to be loaded by compression when the plunger tip is pushed into the final insertion state. The pressure member may be configured to release a mechanical engagement configured to hold the needle in place relative to the syringe body, thereby releasing the needle so that it can be withdrawn proximally in the retracted state. The mechanical coupling can be configured to interact directly with the needle. The mechanical coupling can be configured to interact with a needle interface element that directly interfaces with the needle. The needle interface element may comprise a deformable O-ring. The plunger control assembly may comprise a plunger tip coupler element configured to be intercoupled with the plunger tip. The plunger tip coupler may comprise one or more helical threads configured to be inserted with respect to the plunger tip to couple the plunger tip coupler to the plunger tip. The plunger tip coupler may be fixedly coupled to a plunger insert that has a proximal end configured to be manually manipulated. The system may further comprise a plunger guide flange through which the plunger insert is inserted, the plunger guide flange being detachably attachable to the proximal end of the syringe body. The retraction load may comprise a vacuum load. The retraction load can be developed by an integrated spring element. The retraction load can be developed manually. A locking assembly may be intercoupled between the plunger guide flange and the plunger insert, the locking assembly being configured to prevent retraction of the plunger insert until after the first time it has been inserted to place the plunger tip. plunger in final insertion state. The latch can be configured to reside in a locked state with respect to the plunger guide flange until the plunger insertion element is used to place the plunger tip in the final insertion state, after which the latch can be set to transition to an unlocked state with respect to the plunger guide flange, wherein it is configured to allow the plunger insert to be retracted away from the syringe body.

[0008] One embodiment is directed to a safety syringe system comprising: a ready-to-use syringe assembly comprising a syringe body that forms a fluid reservoir and has proximal and distal ends and a plunger tip positioned within the fluid reservoir in a configuration such that a medical fluid can be contained within the fluid reservoir; a needle assembly detachably attachable to the distal end of the syringe body, so that medical fluid can be transferred through a retractable needle attached to a needle housing comprising the needle assembly upon insertion of the plunger tip into relation to the syringe body; and a plunger control assembly coupled to the plunger tip and configured to facilitate manual insertion of the plunger tip relative to the syringe body; wherein, upon insertion of the plunger tip into a final insertion state and release of an associated insertion manual load, the plunger tip may be proximally withdrawn by pulling the retractable needle proximally with respect to the needle housing into a retracted state , in which a distal tip of the needle becomes mechanically locked into an encapsulated configuration, in which it is no longer exposed for injection. Syringe body, plunger control assembly and plunger tip can be configured so that a vacuum charge causes the plunger tip to be automatically withdrawn upon reaching the final insertion state and manual insertion charge release . Syringe body, plunger control assembly and plunger tip can be configured so that a spring load causes the plunger tip to be automatically withdrawn upon reaching the final insertion state and manual insertion load release . A spring configured to provide the spring load is operatively coupled between the retractable needle and the distal end of the syringe body. A spring configured to provide the spring load is operatively coupled between a proximal end of the syringe barrel and the plunger insert coupled to the plunger tip. The fluid reservoir may comprise a substantially cylindrical volume. The syringe body may comprise a glass material. The syringe body may comprise a polymeric material. The plunger tip may comprise an elastomeric material. The elastomeric material may comprise a butyl based rubber. The needle may comprise a hypodermic needle. The hypodermic needle may comprise a standard size between about 20 gauge and about 34 gauge. The needle assembly may comprise a needle insertion prevention member configured to prevent reinsertion of the needle with respect to the syringe barrel after the needle has been placed in the retracted state. The insertion prevention member may be configured to travel along an axis that is substantially perpendicular to a longitudinal axis of the needle. The system may further comprise a release member operatively coupled to the insertion-prevention member and configured to remove an insertion-prevention member's attachment restriction when the plunger tip reaches the final insertion state. The release member may comprise a pressure member configured to be loaded by compression when the plunger tip is pushed into the final insertion state. The pressure member may be configured to release a mechanical engagement configured to hold the needle in place relative to the syringe body, thereby releasing the needle so that it can be withdrawn proximally in the retracted state. The mechanical coupling can be configured to interact directly with the needle. The mechanical coupling can be configured to interact with a needle interface element that directly interfaces with the needle. The needle interface element may comprise a deformable O-ring. The plunger control assembly may comprise a plunger tip coupler element configured to be intercoupled with the plunger tip. The plunger tip coupler may comprise one or more helical threads configured to be inserted with respect to the plunger tip to couple the plunger tip coupler to the plunger tip. The plunger tip coupler may be fixedly coupled to a plunger insert that has a proximal end configured to be manually manipulated. The system may further comprise a plunger guide flange through which the plunger insert is inserted, the plunger guide flange being detachably attachable to the proximal end of the syringe body. The retraction load may comprise a vacuum load. The retraction load can be developed by an integrated spring element. The retraction load can be developed manually. A locking assembly may be intercoupled between the plunger guide flange and the plunger insert, the locking assembly being configured to prevent retraction of the plunger insert until after the first time it has been inserted to place the plunger tip. plunger in final insertion state. The latch can be configured to reside in a locked state with respect to the plunger guide flange until the plunger insertion element is used to place the plunger tip in the final insertion state, after which the latch can be set to transition to an unlocked state with respect to the plunger guide flange, wherein it is configured to allow the plunger insert to be retracted away from the syringe body.

[0009] One embodiment is directed to a safety syringe system comprising: a syringe body that forms a fluid reservoir and that has proximal and distal ends; a plunger tip positioned within the fluid reservoir in a configuration such that medical fluid can be contained within the fluid reservoir; a needle assembly detachably attachable to the distal end of the syringe body, so that medical fluid can be transferred through a retractable needle attached to a needle housing comprising the needle assembly upon insertion of the plunger tip into relation to the syringe body; and a plunger control assembly coupled to the plunger tip and configured to facilitate manual insertion of the plunger tip relative to the syringe body; wherein, upon insertion of the plunger tip into a final insertion state and release of an associated manual insertion load, a retraction load coupled between the syringe barrel and the plunger tip causes the plunger tip to be proximally withdrawn by pulling the retractable needle proximally of the needle housing into a retracted state, in which a distal tip of the needle becomes mechanically locked into an encapsulated configuration, in which it is no longer exposed for injection. The fluid reservoir may comprise a substantially cylindrical volume. The syringe body may comprise a glass material. The syringe body may comprise a polymeric material. The plunger tip may comprise an elastomeric material. The elastomeric material may comprise a butyl based rubber. The needle may comprise a hypodermic needle. The hypodermic needle may comprise a standard size between about 20 gauge and about 34 gauge. The system may be configured so that upon insertion of the plunger tip into a final insertion state and release of an associated manual insertion load , a retraction load coupled between the syringe body and the plunger tip causes the plunger tip to be withdrawn proximally, pulling the retractable needle proximally with respect to the needle housing to a retracted state, where a distal tip of the needle becomes mechanically locked in an encapsulated configuration, in which it is no longer exposed for injection. The needle assembly may comprise a moveable needle insertion prevention member configured to prevent reinsertion of the needle with respect to the syringe body after the needle has been placed in the retracted state. The insertion prevention member may be configured to travel along an axis that is substantially perpendicular to a longitudinal axis of the needle. The system may further comprise a release member operatively coupled to the insertion-prevention member and configured to remove an insertion-prevention member's attachment restriction when the plunger tip reaches the final insertion state. The release member may comprise a pressure member configured to be loaded by compression when the plunger tip is pushed into the final insertion state. The pressure member may be configured to release a mechanical engagement configured to hold the needle in place relative to the syringe body, thereby releasing the needle so that it can be withdrawn proximally in the retracted state. The mechanical coupling can be configured to interact directly with the needle. The mechanical coupling can be configured to interact with a needle interface element that directly interfaces with the needle. The needle interface element may comprise a deformable O-ring. The plunger control assembly may comprise a plunger tip coupler element configured to be intercoupled with the plunger tip. The plunger tip coupler may comprise one or more helical threads configured to be inserted with respect to the plunger tip to couple the plunger tip coupler to the plunger tip. The plunger tip coupler may be fixedly coupled to a plunger insert that has a proximal end configured to be manually manipulated. The system may further comprise a plunger guide flange through which the plunger insert is inserted, the plunger guide flange being detachably attachable to the proximal end of the syringe body. The retraction load may comprise a vacuum load. The retraction load can be developed by an integrated spring element. The retraction load can be developed manually. A locking assembly may be intercoupled between the plunger guide flange and the plunger insert, the locking assembly being configured to prevent retraction of the plunger insert until after the first time it has been inserted to place the plunger tip. plunger in final insertion state. The latch can be configured to reside in a locked state with respect to the plunger guide flange until the plunger insertion element is used to place the plunger tip in the final insertion state, after which the latch can be set to transition to an unlocked state with respect to the plunger guide flange, wherein it is configured to allow the plunger insert to be retracted away from the syringe body.

[0010] One embodiment is directed to a pre-filled safety syringe system comprising: a syringe body that forms a fluid reservoir and that has proximal and distal ends; a plunger tip positioned within the fluid reservoir in a configuration such that a medical fluid is contained within the fluid reservoir; a needle assembly detachably attachable to the distal end of the syringe body, so that medical fluid can be transferred through a retractable needle attached to a needle housing comprising the needle assembly upon insertion of the plunger tip into relation to the syringe body; and a plunger control assembly coupled to the plunger tip and configured to facilitate manual insertion of the plunger tip relative to the syringe body; wherein, when inserting the plunger tip into a final insertion state and releasing an associated manual insertion load, a retraction load coupled between the syringe body and the plunger tip causes the plunger tip to be proximally withdrawn by pulling the retractable needle proximally of the needle housing into a retracted state, in which a distal tip of the needle becomes mechanically locked into an encapsulated configuration, in which it is no longer exposed for injection. The fluid reservoir may comprise a substantially cylindrical volume. The syringe body may comprise a glass material. The syringe body may comprise a polymeric material. The plunger tip may comprise an elastomeric material. The elastomeric material may comprise a butyl based rubber. The needle may comprise a hypodermic needle. The hypodermic needle may comprise a standard size between about 20 gauge and about 34 gauge. The needle assembly may comprise a moveable needle insertion prevention member configured to prevent reinsertion of the needle with respect to the syringe body after the needle have been placed in the retracted state. The insertion prevention member may be configured to travel along an axis that is substantially perpendicular to a longitudinal axis of the needle. The system may further comprise a release member operatively coupled to the insertion-prevention member and configured to remove an insertion-prevention member's attachment restriction when the plunger tip reaches the final insertion state. The release member may comprise a pressure member configured to be loaded by compression when the plunger tip is pushed into the final insertion state. The pressure member may be configured to release a mechanical engagement configured to hold the needle in place relative to the syringe body, thereby releasing the needle so that it can be withdrawn proximally in the retracted state. The mechanical coupling can be configured to interact directly with the needle. The mechanical coupling can be configured to interact with a needle interface element that directly interfaces with the needle. The needle interface element may comprise a deformable O-ring. The plunger control assembly may comprise a plunger tip coupler element configured to be intercoupled with the plunger tip. The plunger tip coupler may comprise one or more helical threads configured to be inserted with respect to the plunger tip to couple the plunger tip coupler to the plunger tip. The plunger tip coupler may be fixedly coupled to a plunger insert that has a proximal end configured to be manually manipulated. The system may further comprise a plunger guide flange through which the plunger insert is inserted, the plunger guide flange being detachably attachable to the proximal end of the syringe body. The retraction load may comprise a vacuum load. The retraction load can be developed by an integrated spring element. The retraction load can be developed manually. A locking assembly may be intercoupled between the plunger guide flange and the plunger insert, the locking assembly being configured to prevent retraction of the plunger insert until after the first time it has been inserted to place the plunger tip. plunger in final insertion state. The latch can be configured to reside in a locked state with respect to the plunger guide flange until the plunger insertion element is used to place the plunger tip in the final insertion state, after which the latch can be set to transition to an unlocked state with respect to the plunger guide flange, wherein it is configured to allow the plunger insert to be retracted away from the syringe body. The fluid reservoir may further comprise a commercially available ready-to-use syringe body, plunger tip and tip cap. Brief Description of Drawings

[0011] Figures 1-5B illustrate various aspects of conventional injection syringe configurations.

[0012] Figures 6-10K illustrate various aspects of a safety syringe configuration in accordance with the present invention.

[0013] Figure 11 illustrates a process for performing an injection procedure using a safety syringe configuration as described with reference to Figures 6-10K.

[0014] Figures 12A-12G illustrate various aspects of a safety syringe configuration in accordance with the present invention.

[0015] Figure 13 illustrates a process for configuring a safety syringe as described in reference 12A-12G.

[0016] Figures 14A-14G illustrate various aspects of a safety syringe configuration in accordance with the present invention.

[0017] Figure 15 illustrates a process for performing an injection procedure using a safety syringe configuration as described in reference to Figures 14A-14G.

[0018] Figures 16A-16H illustrate various aspects of a safety syringe configuration in accordance with the present invention.

[0019] Figure 17 illustrates a process for performing an injection procedure using a safety syringe configuration as described in reference to Figures 16A-16H.

[0020] Figures 18A-18I illustrate various aspects of a safety syringe configuration in accordance with the present invention.

[0021] Figure 19 illustrates a process for performing an injection procedure using a safety syringe configuration as described with reference to Figures 18A-18I.

[0022] Figures 20A-20I illustrate various aspects of a safety syringe configuration in accordance with the present invention.

[0023] Figure 21 illustrates a process for performing an injection procedure using a safety syringe configuration as described with reference to Figures 20A-20I.

[0024] Figures 22A-22K illustrate various aspects of a safety syringe configuration in accordance with the present invention.

[0025] Figure 23 illustrates various aspects of a safety syringe configuration in accordance with the present invention.

[0026] Figure 24 illustrates various aspects of a safety syringe configuration in accordance with the present invention.

Detailed Description of the Invention

[0027] Referring to Figure 6, an exploded view of a safety syringe assembly comprising a needle assembly (32) which can be removably coupled to a ready-to-use syringe body (34) is illustrated. which forms a reservoir (40) which may be at least partially pre-filled with a fluid, such as a liquid medicinal product. The distal end of the syringe body is configured to have a Luer-type coupling interface (42), while the proximal end of the syringe body comprises a conventional syringe flange (38), such as that known as a flange configuration. "Gerresheimer". The syringe body (34) preferably comprises a translucent material, such as glass or polymer. To form a contained volume within the reservoir (40) and assist in expelling the associated fluid through the needle, a plunger tip (36) may be positioned within the syringe body (34). The syringe body may be substantially cylindrical in shape (i.e., so that a plunger tip 36 having a circular cross-sectional shape can establish a seal against the syringe body) or be configured to have other cross-sectional shapes. , such as an ellipse. A plunger control assembly (44) is configured to be coupled to the body of the syringe and to engage the plunger tip (36) to assist in expelling fluid from the syringe through the needle and withdrawing the needle, as described below. As described above, the syringe barrel flange (38) may comprise a conventional flange geometry which may be chosen from the syringe barrel supplier; preferably, the piston control assembly (44) can be configured to be attachable to most conventionally available flange geometries (38), such as various sizes of flanges available from suppliers such as Gerresheimer, as noted above. Plunger tip (36) may comprise a normal butyl rubber material and may be coated, such as with a biocompatible lubricating coating, to facilitate preferred sealing characteristics and relative movement against the syringe barrel structure and associated material.

[0028] Referring to Figure 7A, an expanded orthogonal view of an embodiment of a needle assembly (32) is illustrated showing a needle cover (46) configured to form a cover or shield at least over the distal end of the needle. (58) when mounted. A distal needle housing member (48) and a proximal needle housing member (50) help maintain the position of the needle with respect to the syringe body and control movement of a locking mechanism comprising an engaging member with two fingers (54) removably coupled to a movable needle insertion prevention member (56). The needle element has a pointed distal end (58) configured to be hypodermically inserted into a tissue structure of a patient; a proximal end (60) comprising a proximal tip interface (62) that can be configured to pierce and engage with a portion of an associated plunger tip, so as to somewhat mimic the function of a harpoon instrument.

[0029] Referring to Figure 7A, an expanded orthogonal view of an embodiment of a plunger control assembly (44) is illustrated, which shows a plunger insertion element (74) that interfaces with a tip coupler element. distally located plunger (64), which may have external helical threads configured to "screw" into and mate with the deformable material of an associated plunger tip as desired, a proximal plunger insert handling interface (76), a latch member (68) and a sealing flange assembly (66) comprising a flange member (72) configured to be removably coupled to the proximal flange connector of a conventional syringe barrel (such as that shown in Fig. 6 as member 38) for retaining a syringe barrel proximal plug member (88), with an additional sealing interface comprising an oring ring (70) to facilitate the build-up of a vacuum charge when using an associated plunger tip is inserted relative to the sealing flange assembly (88). The proximal plunger insert (76) manipulation interface is preferably shaped to allow manipulation with a finger and/or thumb in a manner similar to that associated with conventional syringe operation (i.e., depression with a thumb or finger, while one or more of the other fingers are used to apply a counter load to the flange area). Figure 8 illustrates a partially assembled configuration in which a syringe body has been coupled to a plunger control assembly (44) with the plunger tip coupler element (64) helically advanced and coupled to the proximal component of the plunger tip. collapsible plunger (36) and flange member (72) coupled to the proximal flange member of the syringe body (34). The needle cover (46) is preferably configured to protect/cover not only the distal component of the needle element (58) but also the proximal component (60, 62) in the depicted configuration, as shown, to allow an operator manually grasps the needle assembly (32) as shown and attaches it to the distal component of the syringe body (34) without putting the operator's fingers at risk of accidental needle puncture.

[0030] Referring to Figure 9A, the rather large overlap between the distal end (80) of the syringe barrel outer diameter and the interface end (78) of the needle cover provides a relatively large geometrical guidance surface for aligning the proximal end of the needle (60) as it is guided through the needle assembly components during assembly/coupling with the syringe body (34) and oriented in fluid contact with the syringe body fluid reservoir (34).

[0031] Referring to Figure 9B, a flange member (72) is shown in relation to a syringe body (34) and plunger insert (74) intercoupled. In the illustrated embodiment, the mechanical interface between the plunger insert (74) and the flange element (72) is a latch element or latch assembly (68) that is configured to be snap-mounted within a recess formed. on the flange element (72). Figure 9C illustrates an opposite orthogonal view. Figure 9D illustrates a flange member (72) without the locking member in place to show the recess surface (86) formed in the flange member (72). Figure 9E shows a locking element (68) having two external mounting release tabs (82) and two internal locking tabs (84). In this embodiment, the locking element (68) is configured to be fitted into the recess of the flange element (86) and held in place by geometric details coupled to the external mounting release tabs (82). In such a position, the two inner locking tabs (84) are geometrically conditioned toward the distal end of the syringe body so that they are easily moved away (i.e., inserted through the two inner locking tabs 84) of an element. plunger insert (element 74 in other drawings; not shown in Figures 9D and 9E) during such insertion with relatively low friction - but also resist retraction of the same plunger insert with relatively high loads until released from coupling to the plunger insert. flange (72). Such a release can be accomplished by pressing the two outer mounting release tabs (82) - and indeed these tabs (82) are configured to be automatically depressed by such release upon full insertion of the plunger insertion element into a state where the associated plunger tip is interfaced against the end of the syringe and where the proximal interface of the plunger insert (element 76 in Figure 7B, for example) is interfaced against the mounting release tabs external elements (82) so that they are released and the locking element (68) is allowed to move along with the plunger insert, as shown in Figure 10I, without further retraction of the plunger insert resistance. associated.

[0032] Referring to Figure 10A-10K, various configurations of the safety syringe in accordance with the present invention are illustrated. Referring to Figure 10A, with a needle assembly coupled to a syringe body (34), the protective needle cover (46) can be removed as shown to expose the distal portion of the needle (58) for injection into a housing. tissue from a patient. The needle assembly's internal support mechanisms can be configured to withstand an injection load of approximately 2.27 kg (5 lbs) without sagging or slipping - to meet a standard such as those promulgated by organizations such as ISO . In the illustrated embodiment, the proximal end (60) of the needle is configured to extend into the fluid reservoir (40) of the syringe body to become a conduit for fluid for injection into a tissue structure that may be temporarily interfaced with a distal portion (58) of the needle. The needle is threaded through a movable needle insertion prevention element (56), which imparts only very small frictional loads to the needle in the configuration shown, wherein the needle is threaded directly through the needle insertion prevention element. needle (56). Referring to the enlarged view of Figure 10B, with full insertion of the plunger tip to a final insertion state, the plunger is configured to transmit a compressive load on the needle and/or a sleeve attached thereto to drive the snagging element. inserting a needle (56) against the clamp or two fingers of the engaging element (54), thereby keeping them away from each other (90). The geometry and structural modules of these structures can be configured so that, upon full insertion of the plunger tip into a final insertion state, a geometric notch (element 110, as illustrated in Figure 10C) of the needle insertion prevention element (56) movable is pushed past the two fingers of the engaging element (54), so that the needle insertion prevention element (56) is held in position by virtue of the raised surfaces (element 108, as illustrated in the figure). 10C), wherein it will remain conditioned open - and equally conditioned to move in a direction (parallel to axis 96 illustrated in Figure 10D) substantially perpendicular to the longitudinal axis of the needle (element 98 in Figure 10D, for example) if released from the constraint of the needle passing through it. The movable needle insertion prevention element (56) may be at a sliding interface against, and be retained in the axial direction parallel to the longitudinal axis of the needle (98), a wall (112) formed in the distal needle housing element ( 48), as shown in figure 10D. With the two fingers of the conditioned engaging element (54) open, a needle axial position restriction notch (102) formed in the needle and/or a sleeve attached to the needle can be released from the restriction of the engaging element (54) and allowed to retract, as shown in Figure 10D, where the two engagement contact points (92, 94) have been separated enough for the needle to be withdrawn, here by the vacuum load that has developed within the proximal aspect of the syringe body during insertion of the plunger tip. Figures 10E and 10F illustrate sequential images in which the needle insertion prevention element (56) has been pushed past the two fingers of the engaging element (54) to leave it relatively permanently open so that the needle can be withdrawn. Referring to Figure 10G, with sufficient retraction of the needle such that the needle tip (58) is not threaded through a first needle through opening (104) and restricting movement of the movable needle insertion prevention member (56) ), the movable needle insertion prevention element (56) is urged by the compressive load of the fingers of the engaging element (54) on the raised geometry of the movable needle insertion prevention element (56) to move along axis (96), which is substantially perpendicular to the longitudinal axis of the needle (98), thereby bringing the distal tip of the needle (58) into alignment with the partial depth needle opening (106), which is configured to specifically lock and restrict the distal tip of the needle (58) as a successive attempt is made to attempt to insert the needle. Figures 10H-10J illustrate various aspects of the plunger control assembly in relation to the syringe body (34). Referring to Figure 10k, upon complete retraction of the needle into the syringe body (34), the needle may be left at rest or conditioned to rest in an inclined or intentionally misaligned position with respect to the syringe body (34). to avoid reinsertion of the needle in relation to the syringe body (34). In use, the embodiments characterized in Figures 10A-10K may function as follows: a ready-to-use pre-filled syringe body, such as that described with reference to Figure 5A, may be coupled to a plunger control assembly and the needle assembly close to the intended use site; the protective needle cover can be removed and the needle injected into the patient, followed by insertion of the plunger tip to expel fluid from the syringe to the patient; since the plunger tip is seated at the distal end of the syringe body, several events are intended to occur: a) the proximal end of the needle forms a harpoon on the plunger tip to couple these two structures; b) a plunger retraction lock is released by the interface of the proximal plunger insert and the outer tabs of the lock member, so that the plunger insert and the plunger tip and harpoon needle intercoupled can be withdrawn in relation to the syringe body; c) a vacuum load is maintained by the proximal volume substantially sealed between the flange assembly (66) and the plunger tip, which is expanded as the plunger tip is inserted; d) a moveable needle insertion prevention member (56) opens the fingers of the associated engaging member (54) to allow the needle to become relatively unrestricted in terms of proximal retraction or withdrawal into/into the syringe body - and upon sufficient retraction of the needle (e.g., through the vacuum load pulling the plunger tip, which is harpooned to the needle, so that the needle is pulled proximally in retraction), the movable pinch-prevention element needle insert (56) moves to prevent further reinsertion of the needle tip. Thus, a single-use safety syringe configuration is described, in which a single insertion for injection is made relatively simply, while several mechanisms interact to allow controlled retraction of the needle and prevention of reinsertion after retraction. During insertion for injection, the locking element of the plunger control assembly allows an operator to completely remove their hands from the system while the lock maintains the position of the plunger tip in relation to the syringe barrel. The locking element can also be effective in maintaining the geometric relationship between the plunger tip and an associated syringe body and the volume of pre-filled medicament captured during transport and handling prior to use. For example, with conventional configurations, such as the one shown in Figure 5A, it is possible that changes in pressure, such as those created by transporting air, could move the plunger tip relative to the syringe barrel - possibly beyond limits/ acceptable sterile geometric barriers. Such relative movement can be avoided with a lock/lock configuration as described here.

[0033] Referring to Figure 11, a process for using an embodiment such as that described with reference to Figures 10A-10K is illustrated. After preoperative diagnosis and patient preparation (200), a safety syringe injection assembly can be assembled (202). When an injection is desired, the protective cover of the needle can be removed (204) and the injection performed over a tissue structure of the patient (206, 208). After the plunger tip reaches a final insertion state, the accumulated vacuum charge can be used to assist in withdrawing the plunger tip proximally to a retracted state (210); such insertion into the final insertion state and subsequent retraction of the needle may cause the movable needle insertion prevention member to move into a configuration that will prevent reinsertion of the needle (212); Insertion of the plunger tip to the final insertion state also causes the plunger locking member to mechanically change to an unlocked state, wherein retraction of the plunger is not mechanically resisted by the lock (214). The retracted needle can be completely retracted into the syringe barrel and positioned in a angled configuration to prevent further insertion (216).

[0034] Referring to Figures 12A-12G, another embodiment is depicted in which a mechanism is configured to allow complete injection insertion, after which the needle can be withdrawn automatically and, in certain embodiments, also reinsertion prevented. For simplicity of illustration, locking elements such as those described with reference to Figures 9A-10K are not shown in the embodiments of Figures 12A-12G, but they may be present in certain variations and configurations and are described, for example, in the embodiment of figure 13.

[0035] Referring to Figures 12A-12G, a safety syringe assembly is described, wherein a needle housing (120) can be coupled to a conventional syringe body (34) and used to facilitate a single complete insertion of the syringe. needle, after which needle withdrawal can be facilitated automatically by a combination of converting the withdrawal prevention mechanism to a state where needle withdrawal is freely permitted and a vacuum load developed on the captured volume proximal to the plunger tip in the body of the syringe being allowed to facilitate the withdrawal of the needle, as described above. As shown in Figure 12A, a plunger tip (36) is shown ready to inject the contents of the syringe body (34) into the needle, the distal portion (58) of which may be in direct interface with a tissue structure of the patient. . Referring to Figure 12B, an enlarged view of which is shown in Figure 12D, with the plunger tip (36) almost fully inserted, the needle remains locked in place and withdrawal is prevented by a locking configuration comprising an Oring driven ring. forcefully against a needle sleeve (126) attached to the needle. The proximal end of the needle (60) has a harpoon-like interface (64) configured to pierce the material of the plunger tip (36) and engage therewith. The illustrated embodiment also includes a polymeric support (122) of the plunger tip (36) selected to create a stronger coupling of the needle tip and the plunger. Referring to Figure 12C, an enlarged view of which is shown in Figure 12E, with complete insertion of the plunger tip (36), the needle sleeve (126) urges a load transfer element (128) at least partially through a plurality of engaging elements (130, 131), which rotate (132) as shown in Figure 12E, to release an O-ring loading element (134) from its previous restraint against the O-ring (170). ), allowing the O-ring to relax slightly and thus release the needle from the anterior axial withdrawal constraint, after which retraction of the plunger insert (74), such as by vacuum loading or manually, will pull the needle on withdrawal proximal to the syringe body (34), as shown in figures 12F and 12G.

[0036] Referring to Figure 13, an embodiment similar to that of Figure 11 is illustrated except that, in the embodiment of Figure 13, after insertion for injection (208), insertion to a final insertion state releases compression of an O-ring -ring against the needle, thereby allowing the needle to be withdrawn (218), as described above with reference to Figures 12A-12G.

[0037] Referring to Figures 14A-14G, an embodiment similar to that of Figures 12A-12G is illustrated, except that the embodiment of Figures 14A-14G features a curved or off-axis proximal barb or harpoon interface (136) that is configured to cause a completely withdrawn needle to be angled to the side or out of alignment with the syringe body (34), so that the needle cannot be reinserted by another attempt at insertion of the plunger tip. Figure 15, which is similar to Figure 13, shows the addition of such misalignment of the needle element upon complete withdrawal of the needle element from the syringe body (220) to prevent reinsertion of the needle element relative to the syringe body. syringe (i.e. to prevent reuse or accidental/unwanted contact of a needle tip with a person or object).

[0038] Referring to Figures 16A-16H, an embodiment similar to that of Figures 12A-12G is illustrated, except that the embodiment of Figures 16A-16H shows a curved or off-axis proximal barb or harpoon interface (138) that is configured to cause a completely withdrawn needle to be angled to the side or out of alignment with the syringe body (34), so that the needle cannot be reinserted by another attempt at insertion of the plunger tip - and also provide an even stronger harpoon-like coupling between the proximal portion of the needle (60) and the plunger tip (36). Fig. 17, which is similar to Fig. 13, shows the addition of such misalignment of the needle element after complete withdrawal of the needle element from the syringe body using the double coupling element (222) to avoid reinsertion of the needle element in relation to the syringe barrel (i.e. avoid reuse or accidental/unwanted contact of a needle tip with a person or object).

[0039] Referring to Figures 18A-18I, an embodiment similar to that of Figures 12A-12G is illustrated, except that the embodiment of Figures 18A-18I shows a very different mechanism to allow needle insertion and resist retraction until complete insertion of the needle. needle, after which retraction of the needle is facilitated by deformation of a clamp element (140). For example, referring to the enlarged views of Figures 18D and 18E, in Figure 18D, an enlarged view of the configuration of Figure 18A, the clamp element (140), with two through openings (142, 144) that are slightly out of alignment , prevents movement of the needle (58) relative to the syringe body (34). Fig. 18E shows the plunger tip almost fully, but not fully, inserted with respect to the syringe body, as in Fig. 18B. Upon complete insertion of the plunger tip (36), as in Figures 18C and 18F, a needle sleeve element or a shoulder formed in the external geometry of the needle compresses the clamp element (140), causing openings ( 142, 144) become more aligned, if not completely aligned, whereupon they can be held in such a configuration by an element (148) formed in the needle housing (120) configured to retain such a configuration so that the needle can be removed, such as by a vacuum charge or manually applied charge as described above. In other words, the clamp element (140) can be squeezed by virtue of a physical coupling through the needle assembly to the plunger tip (36), causing deformation (which can be configured to be plastic deformation or elastic deformation, depending on the materials and dimensions selected for the clamp; in an elastic deformation configuration, the retaining member 148 most prominently assists in retaining the deformed shape of the clamp) of the clamp (140) to a shape such as that shown in Figure 18F, in that needle (58) is allowed to retract without substantial resistance by the clip due to alignment of the openings in the clip. Figure 18H shows incomplete withdrawal of the needle from the syringe body; Figure 18I shows the complete withdrawal of the needle from the syringe body, with the withdrawn needle tipping to the side to avoid further insertion of the needle in relation to the syringe body, as described above. The embodiment of Figure 19 is similar to that of Figure 15, except that the embodiment of Figure 19 shows the deformation of a needle retraction resistance clamp, thereby allowing the needle to be withdrawn (224).

[0040] Referring to Figures 20A-20I, an embodiment similar to that of Figures 12A-12G is illustrated, except that the embodiment of Figures 20A-20I shows a very different mechanism for resisting needle retraction until complete needle insertion after which needle retraction is facilitated by movement of a cantilevered engagement member (152) of an engagement assembly (150) coupled to the distal needle housing (120). For example, referring to the enlarged views of figures 20D and 20E, in figure 20D, an enlarged view of the configuration of figure 20A, the engaging element (152) prevents withdrawal of the needle (58) with respect to the syringe body (34) by interfacing with a recess (154) formed in the needle or a sleeve member coupled thereto. Figure 20E shows the plunger tip almost completely, but not completely, inserted with respect to the syringe body, as in Figure 20B. Upon complete insertion of the plunger tip (36), as in Figures 20C and 20F, the needle element and/or needle sleeve (156) advances slightly forward, displacing the engaging element (152) from the recess (154). ), after which the needle can be withdrawn (as shown in figure 20G), such as by a vacuum load or manually applied load as described above. Figure 20H shows incomplete withdrawal of the needle from the syringe body; Figure 20I shows the complete withdrawal of the needle from the syringe body, with the withdrawn needle tipping to the side to avoid further insertion of the needle in relation to the syringe body, as described above. The embodiment of Figure 21 is similar to that of Figure 19, except that the embodiment of Figure 21 shows the mechanical reconfiguration of a needle retraction resistance engagement, thereby allowing the needle to be withdrawn (226).

[0041] Referring to Figures 22A-22K , an embodiment is described wherein a needle assembly has a proximally located intercoupling element (160) configured to be coupled (via relative rotation) to a Luer connector (14) distal end of a conventional syringe assembly and also configured to be coupled (also by means of a relative rotation - preferably the same direction of rotation as the first rotation) to an inner surface of the needle housing (166) in such a way that the proximal component (60, 64) of the needle remains protected from an operator's hands or other objects. Referring to Figure 22A , the needle assembly comprises a needle coupled through a needle housing (166) and intercoupled intercoupling member (160) intercoupled so that the proximal end of the needle (60, 64) does not extend beyond the proximal end of the intercoupling member (160). A removable needle guard (158) isolates the distal portion (58) of the needle and is removable at the time of injection; further, the removable needle guard (158) shows rotational manipulation elements, such as small wing components, to facilitate rotation of the needle assembly with respect to the syringe body (34) to which it is to be attached. Such elements can be particularly useful for the home health care market, where patients suffering from conditions such as arthritis may need to use syringes for injection and have difficulty unaided by physical elements. Referring to Figure 22B, the syringe assembly and needle assembly are brought into contact with the Luer interface of the intercoupling member (160) positioned against the Luer interface of the syringe assembly. With twist fit, the intercoupling begins through the intercoupling element (160), as shown in the cross-sectional view of Figure 22C. As it twists further, the proximal coupling interface (164) of the intercoupling element (160) causes tighter engagement of the intercoupling element (160) using the internal helical thread interface (168) of the needle housing - up to the coupling is complete, as shown in figures 22D and 22E. Subsequently, the removable needle guard (158) can be removed and a fluid injection initiated, as shown in Figures 22F and 22G. Upon complete insertion of the plunger tip (36) with respect to the syringe body (34), the needle proximal harpoon interface (64) can be coupled to the plunger tip (36) and a similar unlocking configuration to that shown in reference Figures 20A-20I may allow proximal withdrawal of the needle, as shown in Figures 22I-22K.

[0042] Referring to figure 23, a configuration similar to that illustrated in figure 12A is illustrated, except that the configuration of figure 23 has an integrated spring element (51) intercoupled between the needle element (58) and the distal end of the syringe body (34) to provide a needle retraction load sufficient to retract the needle as described above - but in the context of a vacuum retraction load.

[0043] Referring to Figure 24, a configuration similar to that illustrated in Figure 12A is illustrated, except that the configuration of Figure 23 has an integrated spring element (101) intercoupled between the proximal end (38) of the syringe body (34) and the proximal end of the plunger insert (74) to provide a needle retraction load sufficient to retract the needle as described above - but in the context of a vacuum retraction load.

[0044] Figures 23 and 24 illustrate that loads other than vacuum loads can be used to assist in the retraction of a needle element with various safety configurations described here. Indeed, in simplified configurations, which may be desirable from cost and other points of view, prevention of needle reinsertion can be achieved using needle assemblies such as those described here, with only manual retraction of the needle element ( (i.e., while several auto-retraction configurations after complete insertion are described here, manual retraction configurations can also benefit from the safety afforded by the needle assemblies described here, where reinsertion of a needle after a first complete insertion is physically prevented).

[0045] Returning to figures 11, 13, 15, 19 and 21, the syringe body (pre-loaded with drugs), needle assembly and plunger control assembly are illustrated (202) as being part of an IN- SITU (ie, adjacent to the point of use - such as in a hospital or home healthcare setting, and after preoperative diagnosis and patient preparation 200). In other embodiments, a plunger control assembly, such as that illustrated in Figures 6 and 7B (44), may arrive at the intervention site pre-assembled with a syringe body (i.e., such an assembly could be pre-assembled before distribution to the intervention site); furthermore, in other embodiments, a needle assembly such as that illustrated in Figures 6 and 7A (32) may arrive at the intervention site pre-assembled with a syringe body (i.e., such an assembly could be pre-assembled prior to distribution to the intervention site); indeed, in other embodiments, both the needle assembly (32) and the plunger control assembly (44) may be pre-assembled with a syringe body at the factory or other location prior to delivery to the intervention site.

[0046] Suitable polymeric materials for the various components of these embodiments include, but are not limited to, acetal, polycarbonate, polyvinyl chloride, polypropylene, polystyrene, ABS, nylon, glass-filled nylon, glass-filled acetal, PEKK, glass-filled PEKK , carbon fiber filled PEKK, COC (cyclic olefin copolymer), COP (cyclic olefin polymer), PEI (Ultem), glass filled PEI and PEKK, as well as copolymers thereof.

[0047] Structural metals suitable for structures such as the plunger insert include, but are not limited to, stainless steel, chromium plated steel, brass, nickel and titanium, as well as alloys thereof.

[0048] Suitable needle element sizes range from about a 34/6 mm gauge long - to about a 20/6.35 cm (2.5 inch) gauge long.

[0049] Several exemplary embodiments of the invention are described herein. Reference is made to these examples in a non-limiting sense. They are provided to illustrate applicable aspects of the invention more broadly. Various changes may be made to the described invention and equivalents may be substituted without departing from the true spirit and scope of the invention. Furthermore, many modifications can be made to adapt a particular situation, material, composition of matter, process, act(s) or process step(s) to the object(s), spirit or scope of the present invention. Furthermore, as will be appreciated by those skilled in the art, each of the individual variations described and illustrated herein has components and features that can be readily separated from or combined with features of any of the other various embodiments without departing from the scope or spirit of the present invention. All such modifications are intended to be within the scope of the claims associated with the present description.

[0050] Any of the devices described for performing the diagnostic or intervention procedures in question may be provided in a packaged combination for use in performing such interventions. These supply "kits" may also include instructions for use and be packaged in sterile trays or containers as commonly used for such purposes.

[0051] The present invention includes methods that can be performed using the present devices. The methods may comprise providing such a suitable device. Such provision may be carried out by the end user. In other words, the act of "provisioning" merely requires the end user to obtain, access, approach, position, configure, activate, turn on or act to provide the device required for the present method. The methods described here can be performed in any order of events cited which is logically possible, as well as in the order of events cited.

[0052] Exemplary aspects of the invention, along with details on material selection and fabrication, have been presented above. As for other details of the present invention, these can be appreciated in connection with the patents and publications cited above, as well as generally known and appreciated by those skilled in the art. For example, those skilled in the art will appreciate that one or more lubricating coatings (e.g., hydrophilic polymers, such as compositions based on polyvinylpyrrolidone, fluoropolymers, such as tetrafluoroethylene, hydrophilic gel, or silicones) can be used in connection with the various parts of the products. devices, such as relatively large interfacial surfaces of movably coupled parts, if desired, for example, to facilitate low friction manipulation or advancement of such objects relative to other portions of the instrument or nearby tissue structures. The same may be true of aspects based on the method of the present invention in terms of additional acts commonly or logically employed.

[0053] Furthermore, although the invention has been described with reference to several examples which optionally incorporate various elements, the invention should not be limited to what is described or indicated as being considered in relation to each variation of the invention. Various changes may be made to the described invention and equivalents (whether cited herein or not included for the sake of brevity) may be substituted without departing from the true spirit and scope of the invention. Furthermore, where a range of values is provided, it should be understood that each intervening value between the upper and lower limits of this range and any other indicated or intervening value in this indicated range is within the scope of the invention.

[0054] Furthermore, it is contemplated that any optional element of the described variations of the invention may be presented and claimed independently or in combination with any one or more of the elements described herein. Reference to a single item includes the possibility that there are several of the same items present. More specifically, as used herein and in the associated claims, the singular forms "a", "an", "the" and "a" include plural references unless specifically indicated otherwise. In other words, the use of articles means "at least one" of the item in question in the above description, as well as in the claims associated with the present description. It should be further noted that such claims may be worded to exclude any optional elements. As such, this statement is intended to serve as a background to the use of such proprietary terminology, such as "solely", "sole", and so on, in connection with citing elements of the claim or using a "negative limitation".

[0055] Without the use of such exclusive terminology, the term "comprising" in the claims associated with the present description will permit the inclusion of any additional element - regardless of whether a certain number of elements is enumerated in such claims - or the addition of an element could be considered as transforming the nature of an element presented in such claims. Except as specifically defined herein, all technical and scientific terms used herein will be given as broad a commonly understood meaning as possible while maintaining the validity of the claim.

[0056] The scope of the present invention should not be limited to the examples presented and/or the present report described, but only by the scope of the language in the claims associated with the present description.

Claims (17)

1. Safety syringe system characterized in that it comprises: a. a syringe body (34) forming a fluid reservoir (40) and having proximal and distal ends (38, 42); B. a plunger tip (36) positioned within the fluid reservoir (40) configured such that a medical fluid can be contained within the fluid reservoir (40); ç. a needle assembly (32) including a needle housing (48, 50) and a retractable needle coupled thereto, wherein the needle assembly (32) is removably attachable to the distal end (42) of the syringe body ( 34) such that medical fluid is transferred through the retractable needle (56, 60) upon insertion of the plunger tip (36) into the syringe body (34), wherein the needle assembly (32) comprises a movable needle insertion prevention element; d. a plunger control assembly (44) connected to the plunger tip (36) and configured to facilitate manual insertion of the plunger tip (36) into the syringe body (34); wherein upon insertion of the plunger tip (36) to a final insertion state and the release of an associated manual insertion load, a retraction load is coupled between the syringe body (34) and the plunger tip (36) causes the plunger tip (36) to be withdrawn proximally by pulling the retractable needle (58, 60) proximally to the needle housing (48, 50) in a retracted state, wherein a distal tip ( 58) the needle (58, 60) is mechanically locked into an encapsulated configuration in the syringe body (34) in which it is no longer exposed for injection; and is. a release member (54, 102) operatively coupled to the needle insertion prevention member (56), wherein the release member (54, 102) comprises a pressure member configured to be loaded by compression when the plunger tip (36) is pushed into the final insertion state, wherein the needle insertion prevention member (56) is configured to prevent reinsertion of the needle into the syringe body (34) after the needle has been placed in the retracted state. , wherein the release element is configured to remove a clamping restriction from the insertion preventing element (56) when the plunger tip (36) reaches the final insertion state, wherein the pressure element is configured to release a mechanical engagement (54) configured to hold the needle in place relative to the syringe body, thereby releasing the needle so that it can be withdrawn proximally in the retracted state. 2. System according to claim 1, characterized in that the fluid reservoir (40) comprises a substantially cylindrical volume. 3. System according to claim 1 or 2, characterized in that the syringe body (34) comprises a glass material. 4. System according to any one of claims 1 to 3, characterized in that the syringe body (34) comprises a polymeric material. 5. System according to any one of claims 1 to 4, characterized in that the plunger tip (36) comprises an elastomeric material. 6. System according to claim 5, characterized in that the elastomeric material comprises a butyl-based rubber. 7. System according to any one of claims 1 to 6, characterized in that the needle (58, 60) is a hypodermic needle. 8. System according to claim 7, characterized in that the hypodermic needle (58, 60) comprises a standard size between about 20 gauge and about 34 gauge. 9. System according to claim 1, characterized in that the insertion prevention element is configured to travel along an axis that is substantially perpendicular to a longitudinal axis of the needle. 10. System according to claim 1, characterized in that the mechanical coupling is configured to interact directly with the needle. 11. System according to claim 1, characterized in that the mechanical coupling is configured to interact with a needle interface element that interfaces directly with the needle. 12. System according to claim 11, characterized in that the needle interface element comprises a deformable O-ring. 13. System according to claim 1, characterized in that the plunger control assembly comprises a plunger tip coupler element configured to be intercoupled with the plunger tip (36). 14. System according to claim 13, characterized in that the plunger tip coupler comprises one or more helical threads configured to be inserted in relation to the plunger tip (36) to couple the plunger tip coupler with the plunger tip (36). 15. System according to claim 13, characterized in that the plunger tip coupler is fixedly connected to a plunger insert (74) that has a proximal end configured to be manually manipulated, the system comprising further a plunger guide flange (72) through which the plunger insert (74) is inserted, the plunger guide flange (72) being removably attachable to the proximal end of the syringe body. 16. System according to claim 15, characterized in that it further comprises a locking assembly (68) that is intercoupled between the plunger guide flange (72) and the plunger insertion element (74), the assembly lock (68) being configured to prevent retraction of the plunger insertion element (74) until after the first time it has been inserted to place the plunger tip (36) in the final insertion state, in which the lock (68) is configured to reside in a locked state with respect to the plunger guide flange (72) until the plunger insertion element (74) is used to place the plunger tip (36) in the final insertion state, after which the locking (68) is configured to mechanically transition to an unlocked state with respect to the plunger guide flange (72), where it is configured to allow the plunger insert (74) to be retracted away from the body of the plunger. syringe. 17. System according to claim 1, characterized in that the retraction load comprises a vacuum load, an integrated spring element or is developed manually.

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